Trial Outcomes & Findings for Bevacizumab in Metastatic Renal Cancer (NCT NCT02627144)
NCT ID: NCT02627144
Last Updated: 2016-08-29
Results Overview
Tumor response was assessed as one of the following: Complete response (CR): disappearance of all target lesions and all pathological lymph nodes below 10 millimeter (mm). Partial response (PR): At least a 30 percent (%) decrease in the sum of diameters of target lesions. Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions.
Recruitment status
COMPLETED
Target enrollment
365 participants
Primary outcome timeframe
Baseline until progression or intolerable toxicity, whichever occurred first, assessed up to 6 years
Results posted on
2016-08-29
Participant Flow
Participant milestones
| Measure |
Advanced and/or Metastatic RCC Participants
Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
|
|---|---|
|
Overall Study
STARTED
|
365
|
|
Overall Study
Treated
|
359
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
365
|
Reasons for withdrawal
| Measure |
Advanced and/or Metastatic RCC Participants
Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
|
|---|---|
|
Overall Study
Serious adverse event
|
32
|
|
Overall Study
Cancer progression
|
171
|
|
Overall Study
Death from cancer
|
20
|
|
Overall Study
Death from other cause
|
8
|
|
Overall Study
Refusal of treatment / poor cooperation
|
38
|
|
Overall Study
Administrative reasons
|
65
|
|
Overall Study
Lost to Follow-up
|
8
|
|
Overall Study
Enrolled, not treated
|
6
|
|
Overall Study
Other
|
17
|
Baseline Characteristics
Bevacizumab in Metastatic Renal Cancer
Baseline characteristics by cohort
| Measure |
Advanced and/or Metastatic RCC Participants
n=359 Participants
Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
|
|---|---|
|
Age, Continuous
|
65.5 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
242 participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
114 participants
n=5 Participants
|
|
Sex/Gender, Customized
Not available
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline until progression or intolerable toxicity, whichever occurred first, assessed up to 6 yearsPopulation: Full analysis set (FAS) included all participants who received at least one dose of study medication and have at least one post dose efficacy assessment, following the intention-to-treat principle. 'Number of participants analyzed' indicate participants with non-missing tumor response data.
Tumor response was assessed as one of the following: Complete response (CR): disappearance of all target lesions and all pathological lymph nodes below 10 millimeter (mm). Partial response (PR): At least a 30 percent (%) decrease in the sum of diameters of target lesions. Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions.
Outcome measures
| Measure |
Advanced and/or Metastatic RCC Participants
n=338 Participants
Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
|
|---|---|
|
Percentage of Participants With Best Overall Tumor Response
PD
|
16.6 percentage of participants
|
|
Percentage of Participants With Best Overall Tumor Response
CR
|
5.3 percentage of participants
|
|
Percentage of Participants With Best Overall Tumor Response
PR
|
21.9 percentage of participants
|
|
Percentage of Participants With Best Overall Tumor Response
SD
|
39.1 percentage of participants
|
|
Percentage of Participants With Best Overall Tumor Response
Not Evaluable
|
17.2 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline until progression or intolerable toxicity, whichever occurred first, assessed up to 6 yearsPopulation: FAS. 'Number of participants analyzed' indicate participants who were evaluable for this measure.
Disease control was defined as having achieved CR, PR, and/or SD during the course of the observation. CR: disappearance of all target lesions and all pathological lymph nodes below 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions.
Outcome measures
| Measure |
Advanced and/or Metastatic RCC Participants
n=338 Participants
Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
|
|---|---|
|
Percentage of Participants With Disease Control
|
66.3 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline until progression or intolerable toxicity or death, whichever occurred first, assessed up to 6 yearsPopulation: FAS
PFS time is defined as time between start of therapy and progression or death. Kaplan-Meier estimate was used for evaluation. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions.
Outcome measures
| Measure |
Advanced and/or Metastatic RCC Participants
n=354 Participants
Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
|
|---|---|
|
Progression-free Survival (PFS) Time
|
10.2 months
Interval 8.6 to 12.6
|
PRIMARY outcome
Timeframe: Baseline until progression or intolerable toxicity or death, whichever occurred first, assessed up to 6 yearsPopulation: FAS
OS time is defined as time between start of therapy and date of death. Kaplan-Meier estimate was used for evaluation.
Outcome measures
| Measure |
Advanced and/or Metastatic RCC Participants
n=354 Participants
Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
|
|---|---|
|
Overall Survival (OS) Time
|
28.7 months
Interval 24.5 to 38.3
|
PRIMARY outcome
Timeframe: Up to 52 weeksPopulation: FAS. Data were not analyzed for this outcome measure as therapy doses and pattern were not recorded numerically.
Outcome measures
Outcome data not reported
Adverse Events
Advanced and/or Metastatic RCC Participants
Serious events: 72 serious events
Other events: 325 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Advanced and/or Metastatic RCC Participants
n=359 participants at risk
Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
|
|---|---|
|
Nervous system disorders
Cerebral haemorrhage
|
1.1%
4/359 • Baseline up to 6 years
Safety set
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.84%
3/359 • Baseline up to 6 years
Safety set
|
|
Nervous system disorders
Epilepsy
|
0.56%
2/359 • Baseline up to 6 years
Safety set
|
|
Nervous system disorders
Syncope
|
0.56%
2/359 • Baseline up to 6 years
Safety set
|
|
Nervous system disorders
Transient ischaemic attack
|
0.56%
2/359 • Baseline up to 6 years
Safety set
|
|
General disorders
General physical health deterioration
|
1.7%
6/359 • Baseline up to 6 years
Safety set
|
|
General disorders
Asthenia
|
0.56%
2/359 • Baseline up to 6 years
Safety set
|
|
General disorders
Death
|
0.56%
2/359 • Baseline up to 6 years
Safety set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.84%
3/359 • Baseline up to 6 years
Safety set
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.56%
2/359 • Baseline up to 6 years
Safety set
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.56%
2/359 • Baseline up to 6 years
Safety set
|
|
Vascular disorders
Hypertension
|
1.7%
6/359 • Baseline up to 6 years
Safety set
|
|
Vascular disorders
Hypertensive crisis
|
0.56%
2/359 • Baseline up to 6 years
Safety set
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.84%
3/359 • Baseline up to 6 years
Safety set
|
|
Gastrointestinal disorders
Diarrhoea
|
0.56%
2/359 • Baseline up to 6 years
Safety set
|
|
Gastrointestinal disorders
Nausea
|
0.56%
2/359 • Baseline up to 6 years
Safety set
|
|
Blood and lymphatic system disorders
Anaemia
|
1.7%
6/359 • Baseline up to 6 years
Safety set
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.56%
2/359 • Baseline up to 6 years
Safety set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
1.9%
7/359 • Baseline up to 6 years
Safety set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.56%
2/359 • Baseline up to 6 years
Safety set
|
|
Infections and infestations
Diverticulitis
|
0.56%
2/359 • Baseline up to 6 years
Safety set
|
|
Infections and infestations
Peritonitis
|
0.56%
2/359 • Baseline up to 6 years
Safety set
|
|
Infections and infestations
Sepsis
|
0.56%
2/359 • Baseline up to 6 years
Safety set
|
|
Psychiatric disorders
Confusional state
|
1.1%
4/359 • Baseline up to 6 years
Safety set
|
|
Cardiac disorders
Atrial fibrillation
|
0.56%
2/359 • Baseline up to 6 years
Safety set
|
|
Cardiac disorders
Cardiac failure
|
0.56%
2/359 • Baseline up to 6 years
Safety set
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.1%
4/359 • Baseline up to 6 years
Safety set
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.84%
3/359 • Baseline up to 6 years
Safety set
|
|
Renal and urinary disorders
Haematuria
|
0.56%
2/359 • Baseline up to 6 years
Safety set
|
|
Investigations
Weight decreased
|
0.56%
2/359 • Baseline up to 6 years
Safety set
|
|
Nervous system disorders
Cerebral atrophy
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Nervous system disorders
Cerebrovascular accident
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Nervous system disorders
Dementia
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Nervous system disorders
Dizziness
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Nervous system disorders
Dysarthria
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Nervous system disorders
Headache
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Nervous system disorders
Hemiparesis
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Nervous system disorders
Leukoencephalopathy
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Nervous system disorders
Orthostatic intolerance
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Nervous system disorders
Paraesthesia
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Nervous system disorders
Paraplegia
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Nervous system disorders
Senile dementia
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Nervous system disorders
Sensory loss
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Nervous system disorders
Visual field defect
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
General disorders
Chest discomfort
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
General disorders
Chest pain
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
General disorders
Gait disturbance
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
General disorders
Impaired healing
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
General disorders
Multi-organ failure
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
General disorders
Pain
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Vascular disorders
Angiodysplasia
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Vascular disorders
Arterial thrombosis
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Vascular disorders
Haemorrhage
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Vascular disorders
Thrombosis
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Vascular disorders
Venous thrombosis
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Gastrointestinal disorders
Abdominal pain
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Gastrointestinal disorders
Ascites
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Gastrointestinal disorders
Melaena
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Gastrointestinal disorders
Vomiting
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Blood and lymphatic system disorders
Haemorrhagic diathesis
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to abdominal wall
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Infections and infestations
Abscess intestinal
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Infections and infestations
Infection
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Infections and infestations
Meningitis viral
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Infections and infestations
Pyelonephritis
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Infections and infestations
Rash pustular
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Infections and infestations
Urinary tract infection
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Psychiatric disorders
Depression
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Psychiatric disorders
Hallucination
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Cardiac disorders
Angina pectoris
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Cardiac disorders
Aortic valve sclerosis
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Cardiac disorders
Bundle branch block left
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Cardiac disorders
Cardiomyopathy
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Cardiac disorders
Mitral valve incompetence
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Cardiac disorders
Myocardial infarction
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Injury, poisoning and procedural complications
Fall
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Injury, poisoning and procedural complications
Overdose
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Renal and urinary disorders
Bladder pain
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Renal and urinary disorders
Bladder tamponade
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Renal and urinary disorders
Dysuria
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Renal and urinary disorders
Renal failure
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Investigations
Blood glucose abnormal
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Eye disorders
Amaurosis
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Eye disorders
Retinal exudates
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Eye disorders
Retinal haemorrhage
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Hepatobiliary disorders
Hepatic failure
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Hepatobiliary disorders
Liver injury
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
|
Nervous system disorders
Sciatica
|
0.28%
1/359 • Baseline up to 6 years
Safety set
|
Other adverse events
| Measure |
Advanced and/or Metastatic RCC Participants
n=359 participants at risk
Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
55.2%
198/359 • Baseline up to 6 years
Safety set
|
|
Blood and lymphatic system disorders
Leukopenia
|
41.8%
150/359 • Baseline up to 6 years
Safety set
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
32.9%
118/359 • Baseline up to 6 years
Safety set
|
|
Blood and lymphatic system disorders
Neutropenia
|
23.1%
83/359 • Baseline up to 6 years
Safety set
|
|
General disorders
Influenza like illness
|
40.7%
146/359 • Baseline up to 6 years
Safety set
|
|
General disorders
Pyrexia
|
32.3%
116/359 • Baseline up to 6 years
Safety set
|
|
General disorders
Pain
|
23.7%
85/359 • Baseline up to 6 years
Safety set
|
|
General disorders
Fatigue
|
11.7%
42/359 • Baseline up to 6 years
Safety set
|
|
General disorders
Spinal pain
|
5.0%
18/359 • Baseline up to 6 years
Safety set
|
|
Gastrointestinal disorders
Nausea
|
39.0%
140/359 • Baseline up to 6 years
Safety set
|
|
Gastrointestinal disorders
Diarrhoea
|
22.3%
80/359 • Baseline up to 6 years
Safety set
|
|
Gastrointestinal disorders
Vomiting
|
18.1%
65/359 • Baseline up to 6 years
Safety set
|
|
Vascular disorders
Hypertension
|
29.8%
107/359 • Baseline up to 6 years
Safety set
|
|
Renal and urinary disorders
Proteinuria
|
25.1%
90/359 • Baseline up to 6 years
Safety set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
36/359 • Baseline up to 6 years
Safety set
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.9%
32/359 • Baseline up to 6 years
Safety set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.5%
27/359 • Baseline up to 6 years
Safety set
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.7%
24/359 • Baseline up to 6 years
Safety set
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.3%
44/359 • Baseline up to 6 years
Safety set
|
|
Nervous system disorders
Headache
|
10.3%
37/359 • Baseline up to 6 years
Safety set
|
|
Nervous system disorders
Dizziness
|
5.8%
21/359 • Baseline up to 6 years
Safety set
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
15.0%
54/359 • Baseline up to 6 years
Safety set
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.5%
34/359 • Baseline up to 6 years
Safety set
|
|
Cardiac disorders
Cardiac failure
|
7.5%
27/359 • Baseline up to 6 years
Safety set
|
|
Investigations
Weight decreased
|
6.4%
23/359 • Baseline up to 6 years
Safety set
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER